Browse hierarchy: [Radiology (RA)](/submissions/RA) → [Subpart B — Diagnostic Devices](/submissions/RA/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 892.1730](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/892.1730) → IZG — System, X-Ray, Photofluorographic

# IZG · System, X-Ray, Photofluorographic

_Radiology · 21 CFR 892.1730 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZG

## Overview

- **Product Code:** IZG
- **Device Name:** System, X-Ray, Photofluorographic
- **Regulation:** [21 CFR 892.1730](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/892.1730)
- **Device Class:** 2
- **Review Panel:** [Radiology](/submissions/RA)
- **3rd-party reviewable:** yes

## Identification

A photofluorographic x-ray system is a device that includes a fluoroscopic x-ray unit and a camera intended to be used to produce, then photograph, a fluoroscopic image of the body. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

## Classification Rationale

Class II (special controls). A discography kit intended for use with a photofluorographic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

## Special Controls

*Classification.* Class II (special controls). A discography kit intended for use with a photofluorographic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

## Recent Cleared Devices (7 of 7)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K960082](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZG/K960082.md) | DISCOGRAPHY KIT | Spinal Specialties, Inc. | Mar 21, 1996 | SESE |
| [K960146](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZG/K960146.md) | G.E. STERILE DISPOSABLE RADIOGRAPHIC CONTRAST TRAY | GE Medical Systems | Feb 27, 1996 | SESE |
| [K913436](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZG/K913436.md) | PXI PNEUMATIC COMPRESSION PADDLE | Brotherston/Pxi | Nov 5, 1992 | SESE |
| [K920393](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZG/K920393.md) | MU125M MOBILE X-RAY SYSTEM | Shimadzu Medical Systems | Apr 6, 1992 | SESE |
| [K910503](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZG/K910503.md) | DISCOGRAPHY KIT | B. Braun of America, Inc. | Oct 7, 1991 | SESK |
| [K903808](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZG/K903808.md) | AMSIS RDS, RADIOGRAPHIC DISCOGRAPHY KIT | Advanced Med/Surg, Inc. | Jan 22, 1991 | SESE |
| [K892659](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZG/K892659.md) | ELECTRODELCA | Oldelft Corp. of America | Nov 21, 1989 | SESE |

## Top Applicants

- Spinal Specialties, Inc. — 1 clearance
- Shimadzu Medical Systems — 1 clearance
- Oldelft Corp. of America — 1 clearance
- GE Medical Systems — 1 clearance
- Brotherston/Pxi — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZG](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZG)

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